背景:为了保留接受耳蜗植入物(CI)的感觉神经性听力损失(SNHL)患者的残余听力,对耳蜗精细结构的插入创伤需要最小化。手术方法包括传统的乳突切除术-鼓室后路切开术(MPT)以到达中耳,然后是耳蜗造口术(CO)或圆窗(RW)方法。两种技术都有其优点和缺点。结构保存的另一个重要方面是电极阵列的设计。使用了两种不同的设计:“直的”侧壁电极阵列(LW)或“预弯曲的”周围钻电极阵列(PM)。有趣的是,直到现在,植入物的最佳手术方法和设计尚不确定。我们的假设是,四种可能的治疗方案之间的听力保留结果存在差异。
方法:我们设计了一个单一中心,多臂,随机对照试验比较四组患者的插入创伤,每个组具有电极阵列类型(LW或PM)和手术方法(RW或CO)的独特组合。总的来说,48名患者将被随机分为这四个干预组之一。我们的主要目标是比较这四组之间的术后听力保留情况。其次,我们的目标是评估结构保存(即,标量易位,每组基底膜破裂或阵列尖端折叠)。第三,我们将通过耳蜗电图(ECochG)比较听力和结构保留的客观结果。
结论:通过耳蜗造口术或圆窗入路植入人工耳蜗,使用不同的电极阵列类型,是严重至深度双侧感音神经性听力损失患者的标准医疗护理,因为这是一个相对简单和低风险的程序,大大有利于患者。然而,残余听力的丧失仍然是一个问题。该试验是第一个随机对照试验,用于评估几种CI治疗方案对听力保护的影响。
背景:荷兰试验注册(NTR)NL8586。于2020年5月4日注册。回顾性注册;注册前包括3/48名参与者。
BACKGROUND: In order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a \"straight\" lateral wall lying electrode array (LW) or a \"pre-curved\" perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that there is a difference in hearing preservation outcomes between the four possible treatment options.
METHODS: We designed a monocenter, multi-arm, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of an electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is the comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar translocation, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG).
CONCLUSIONS: Cochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relatively simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation.
BACKGROUND: Netherlands Trial Register (NTR) NL8586 . Registered on 4 May 2020. Retrospectively registered; 3/48 participants were included before registration.